Owning reading glasses is a part of growing up, but for many people that start wearing them in their later years it can be downright awkward and uncomfortable. Now a new device, just approved by the FDA, may offer certain folks with presbyopia a new way of addressing the condition.
The KAMRA inlay from Acufocus (Irvine, CA) is implanted into the cornea of one of the eyes of the patient, leaving the second one untouched. The device is essentially a 3.8 mm ring with a 1.6 mm aperture in the center. Just like a diaphragm in a camera, having a narrow opening for light to pass through increases image focus. Of course a lot of the peripheral unfocused light is blocked by the implant, but because only one of the eyes gets it, patients will maintain distance vision without losing depth perception.
To help the device stay in place without causing unnecessary irritation to corneal tissue, it has thousands of holes within its body that allow oxygen and nutrients to pass through.
The device is indicated for people 45 to 60 years old that have not had cataract surgery, who have normal distance vision but require reading glasses between +1 and +2.5 diopters of power.
From the FDA:
To evaluate the safety and efficacy of the KAMRA inlay, the FDA reviewed the results of three clinical studies. The results of the main study showed that 83.5 percent of the evaluable 478 participants achieved uncorrected near visual acuity of 20/40 or better at 12 months. This is the level of vision needed to read most text in magazines and newspapers.
The device is not intended for patients who have had cataract surgery or patients with severe dry eye; an active eye infection or inflammation; corneal abnormalities related to thinning and irregular shape of the surface of their eyes; insufficient corneal thickness to withstand the procedure; a recent or recurring herpes eye infection or problems resulting from past infection; uncontrolled glaucoma; uncontrolled diabetes; or active autoimmune or connective tissue disease.
The labeling warns that the device’s safety and effectiveness in patients who have had LASIK or other refractive procedures is unknown.
The KAMRA inlay may cause or worsen dry eye and various vision-related problems, such as glare, halos, night vision problems, and blurry vision. It also can cause corneal complications such as swelling, clouding, thinning and potential perforation, and challenges evaluating and managing eye problems. For patients experiencing vision problems after the surgery, removal of the device may improve vision in some cases. In other cases, decreased vision could become permanent. There is also a potential risk for the focusing power of the eye to change, causing blurry vision and requiring glasses.
Product page: KAMRA inlay…